SPECIFICATION
Appearance | White crystalline powder |
Identification A(IR) | Infrared spectra of standard and sample should meet each other. |
Identification B (Retention time of HPLC) | The retention time of the principal peak of the sampleSolution corresponds to that of the standard solution, as obtained in the Assay. |
Identification C(By TLC) | The Rf value of the major spot in the thin-layerchromatogram of the Product Preparation is the same as that of the Standard Preparation obtained in the test for Related Substances. |
Particle Size (100 mesh) | ≥95% |
Assay | 98.0~102.0% |
Specific Rotation | +84.0° ~+87.5° |
Moisture | ≤2.0% |
PH (10% aqucous solution) | 5.0-7.0 |
Ignited Residue | ≤0.7% |
Methanol | ≤0.1% |
Heavy Metals (as lead) | ≤10 mg/kg |
Arsenic (As) | ≤3 mg/kg |
Lead | ≤1 mg/kg |
Triphenylphosphine Oxide | ≤150 mg/kg |
Hydrolysis Products | ≤0.1 % |
Related Substances | ≤0.5% |
Total Aerobic count | ≤250 cfu/g |
Yeasts & moulds | ≤50 cfu/g |
Coliform | Negative |
E.coli | Negative |
S.aureus | Negative |
Salmonella | Negative |
MOLECULAR STRUCTURE:
Molecular Formula:C12H19Cl3O8